The danger of accidental syringe needle sticks has proven a hazard to healthcare professional since the invention of the syringe. The threat posed by highly toxic medications and communicable diseases such as hepatitis and AIDS, coupled with an increasing safety awareness amidst the healthcare community and the public alike, creates an extreme demand for products which protect patients and professionals alike.
In April 1981, the American Journal of Medicine reported approximately one-third of all work-related accidents were needle stick injuries. A more recent study by Biomedical Business International, which was cited in the April 1988 issue of Medical Device & Diagnostic Industry, states 800,000 accidental needle sticks were recorded in 1987. With the increased risk posed by the HTLV iii virus (AIDS), this threat becomes more serious, imposing tremendous costs upon individual and healthcare institutions.
Many new products have been developed which attempt to reduce the possibility of accidental needle sticks. Most of these involve a protective sheath which encloses the needle after use. Some of these inventions also relate to the safe isolation and disposal of infected syringe needles.
One such popular device, described in U.S. Pat. No. 4,778,453 (Lopez), is manufactured by ICU Medical, Inc. This device requires a needle extended beyond its normal length. A sliding guard piece resides at the top of the needle adjacent to the syringe body. This guard may be slid down by an operator to cover the tip of the needle, thereby preventing an accidental needle stick. In this arrangement, the healthcare professional must move a hand close to the needle tip while operating the device, thereby potentially increasing the chance for an accidental stick. Additionally, this device does not enclose the entire shaft of the needle, and may not provide an accurate indication of prior use, if the sliding cover does not remain in its protective position, or if it is not moved into its position about the needle tip.
Other recently developed protective devices of interest, although not of direct bearing to the present invention, are disclosed in U.S. Pat. No. 4,747,830to Gloyer, U.S. Pat. No. 4,752,290 to schramm, U.S. Pat. No. 4,758,230 to Rycroft, U.S. Pat. No. 4,758,231 to Harber, U.S. Pat. No. 4,772,272 to Schwartz, U.S. Pat. No. 4,747,835 to Sandhaus, U.S. Pat. No. 4,762,516 to Luther et al., U.S. Pat. No. 4,767,412 to Hyman, and U.S. Pat. No. 4,795,443 to Permenter.
U.S. Pat. No. 4,747,836 to Luther is of interest to the present disclosure. This patent describe a needle guard assembly that comprises two major parts, a needle guard that normally fits over the needle and a separate locking ring mounted on the guard. The needle guard is displaced away from the needle prior to use of the needle, and after such use is replaced over the needle and secured with the locking ring, which rotatably slides over and locks the guard in place over the contaminated needle. However, Luther's assembly does not provide a sterile sealing arrangement which may be used to package the sterile needle prior to use, does not include a fingertab, cannot be operated easily with one hand, does not effectively indicate prior use of the needle, and does not secure the needle within the guard in a manner which substantially discourages reuse. Furthermore, the Luther device must be manipulated by moving a free hand towards the needle tip, potentially increasing the risk of a needle stick.
U.S. Pat. No. 3,658,061 to Hall also describes a needle guard which is placed over the needle in a rotating action. This guard snaps over the needle and thereby prevents accidental stick. It is specifically intended to be used in parenteral fluid administration. Like Luther, this invention also fails to address the opportunities envisioned for a safety guard which may double as the initial needle package, is conducive to one-handed operation, and provides positive indication of needle security and prior use. Hall does not securely lock over the needle to effectively prevent reuse, nor does it prevent an accidental needle stick or contamination during the deployment process of the guard itself. Once again, the deployment of the device may actually increase the chances for a needle stick.
A syringe safety cover which inexpensively and effectively resolves or minimizes the problems associated with the present art would address a large and growing health concern.